RESEARCH ON THE REDUCTION AND PREVENTION OF SUICIDALITY
RELEASE DATE: August 7, 2003
PA NUMBER: PA-03-161
Updates:June 2, 2006 - The R01 portion of this PA has been reissued as PA-06-438 as
of June 2, 2006.
March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission. Parent
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been
issued for the submission date of June 1, 2006 and submission dates for AIDS and
non-AIDS applications thereafter. Applications relating to R33 and R34 activities
must be in response to NIH Institute/Center (IC)-specific announcements.
EXPIRATION DATE for R03, R21 and R34 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03, R21 and R34 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R01 Applications: June 2, 2006
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242, 93.279, 93.891,
93.866, 93.393
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute of Mental Health (NIMH), National Institute on Alcohol
Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), National
Cancer Institute, and the National Institute on Aging invite grant applications
for research that will reduce the burden of suicidality (deaths, attempts, and
ideation). While NIMH has a long-standing commitment to studying the mental
health-related factors contributing to suicide risk, NIDA, NIAAA, NCI, and NIA
supported research in suicidality is growing and has provided a broader
perspective on the range of risk and protective factors. For this PA, mental
disorders, along with alcohol use disorders (AUDs) and substance use disorders
(SUDs) and their respective trajectories, are of particular interest as they
pertain to risk and protective factors and treatment efficacy and effectiveness
for suicidality. The intent of the program announcement is to intensify
investigator-initiated research on this topic, to attract new investigators to
the field, and increase interdisciplinary approaches to developing effective
strategies to reduce suicidality.
RESEARCH OBJECTIVES
Background
In 2000, 29,350 persons died by suicide in the United States. Suicide deaths
outnumbered homicide deaths by 5 to 3. Suicide was the third leading cause of
death for 10-24 year olds, and the eighth leading cause of death for males.
Vital statistics indicate that suicide rates vary dramatically by demographic
characteristics. Males die by suicide more frequently than females by a ratio
of 4 to 1. Older white males have the highest suicide rate, followed by young
American Indian and Native Alaska males. In contrast, older African American
females have one of the lowest rates. Married persons have lower rates than
unmarried persons. Rural suicide rates exceed those in urban areas, and state
rates vary by region, with Western mountain states having the highest suicide
rates in the Nation.
The health conditions most consistently associated with suicide are mental
illness, SUDs and AUDs, affecting up to 90% of all people who die by suicide.
The lifetime risk for suicide death among alcohol-dependent individuals has
been estimated to be 7 to 10%, and among persons with affective disorders, 2
to 7%. Family history of suicide, an individual's prior history of suicide
attempts and serious ideation are also significantly associated with subsequent
suicide death. Despite these strong associations, only a small proportion of
persons with these disorders and family history die by suicide, raising
important questions regarding what protective factors operate among persons with
multiple risk factors. Most medical illnesses are not associated with an
increased risk for suicide. However, individuals diagnosed with HIV/AIDS,
multiple sclerosis, brain cancers have been found to have increased risk for
suicide. Patients with cancers who also have depression, unrelieved pain, and
deteriorating functional ability, have been reported to have higher rates of
suicide ideation.
Suicide attempts and serious suicide ideation (e.g., thoughts that include suicide
plans), each more frequent than suicide deaths, also carry a substantial
health burden. For the year 2000, estimates of the number of persons treated
annually for self-inflicted injuries, most of which are suicide attempts, range
from 264,000 to 864,000. Another estimated 50 percent of persons who attempt
suicide do not seek treatment. In addition to the burden from physical harm
consequent to the behavior, suicide attempts are associated with an increase in
the risk of later suicide death by 40-fold. Persons with mental disorders, SUDs
and AUDs have increased risk for suicide attempts. Intentional overdose with
drugs of abuse or prescription drugs is a common method of suicide attempt,
particularly among women. Persons with AUD and a history of an attempt have a
greater than 20-fold increased risk for subsequent suicide death. Among
alcohol-dependent individuals, those with a history of suicide attempts are more
often female, younger, currently unemployed, separated or divorced, and have
fewer years of education. Serious suicide ideation is more frequent among
youth than adults, and is associated with other high-risk behaviors. Annual
surveys indicate that 1 in 5 high school students report suicide ideation in
the past year.
There have been substantial strides in our understanding of suicide risk
factors, and early progress in clinical trials focused on reducing suicidal
behaviors per se. Research in this area has been invigorated further by the
recognition that suicidality, with its related mortality and morbidity,
represents a significant, and usually preventable loss of human life. A number
of recent federal, national and international reports have proposed a public
health framework from which to develop strategies to reduce known risk factors
and increase protective factors. The reports include those from the World
Health Organization
(http://www5.who.int/violence_injury_prevention/main.cfm?p=0000000117),
the National Strategy for Suicide Prevention
(http://www.mentalhealth.org/suicideprevention/default.asp), a recent
IOM report (http://www.nap.edu/books/0309083214/html/),
and various Surgeon General's Reports on suicide
(http://www.surgeongeneral.gov/library/calltoaction/default.htm) and
mental health (http://www.surgeongeneral.gov/library/mentalhealth/home.html
and http://www.surgeongeneral.gov/library/mentalhealth/cre/).
This program announcement highlights areas of research that can facilitate the
development, implementation, and/or testing of interventions that show promise
of preventing and reducing suicidality.
Areas of Research Opportunities
Investigators are advised to carefully consider definitions of suicidality
(see O'Carroll, et al. (1996), Beyond the Tower of Babel: A Nomenclature for
Suicidology, Suicide & Life-Threatening Behavior, 26 (3), 237-252) and
approaches to measurement (see http://www.nimh.nih.gov/research/measures.pdf
and http://www.nimh.nih.gov/research/adultsuicide.pdf),
theoretical models of distal and proximal risk and protective factors, and
models of behavioral and social change that have implications for reducing
suicide risk.
a. Risk and Protective Factors
Psychological and Cultural Factors. Much has been learned about suicidality and
associated psychological risk factors including hopelessness, shame, and the
significance of stressful life events such as physical, psychological and sexual
abuse, and interpersonal and financial losses. Less understood are other risk
and protective factors and their interactions, such as:
o Individually perceived protective factors (e.g., reasons for living) in the
context of known risk factors, such as a history of sexual abuse, or a severe
and recurring mental disorder, AUD and SUD
o Trait or state dimensions, such as impulsivity or impaired executive
functioning, that increase risk
o The role of cultural factors and acculturative processes that can modify risk
and its perception as well as influencing protective factors (e.g.,
religiousity)
o The effects on trajectories of comorbid mental disorders, SUDs and AUDs and
how those interface with suicidality
Biological and Genetic Factors. Various serotonin receptor and noradrenergic
system abnormalities have been linked to suicide death and attempts. There are
estimates that the heritability of liability to suicidal behavior ranges from
30-50 percent, and this high loading is likely due to the potential
contributions of multiple genes, in addition to shared family environments that
include living with mental disorders and stressful life events. Research
efforts to partition suicide risk to various genetic and neurotransmitter
abnormalities have been limited by the short supply of characterized populations
at high risk for suicide, as well as the low availability of autopsied brains
of suicide victims. Studies of biological and genetic factors include:
o Genetic samples from characterized populations at high risk for suicide that
are reliable phenotypes (e.g., persons with suicide attempt histories) should be
further studied for genetic analyses. Existing twin registries of mental
disorders, SUDs and/or AUDs could be used to explore phenotypic reliability and
gene/environment interactions.
o Additional research to elucidate the neurobiological basis of suicide and
suicidal behavior through cellular, neurochemical, and molecular studies.
Examples include neuroimaging studies elucidating brain changes in treatment
trials; postmortem brain analysis and human neuroimaging.
o Determination of the biological and behavioral overlaps of mental disorders,
AUDs and SUDs with regard to suicide risk. Do these conditions share similar
neuronal circuit pathways? Do they interact in ways that cause an increase in
severity of one or both conditions?
o Studies using animal models to examine state/trait dimensions of impulsivity
with in vivo techniques; examining developmental trajectories of animals with
gene knockouts related to putative risk or protective factors
b. Clinical Trials
The established efficacy of most treatments for mental disorders is based on
data from individuals at low risk for suicidal behavior. With the exception of
the newly approved clozapine indication for reduction of suicidality among
persons with schizophrenia, no psychotropic medications have been tested to
determine whether they are effective in reducing suicidality in randomized
trials. Almost 40% of treatment-seeking AUD patients report a history of
attempting suicide. Several psychosocial and behavioral interventions targeting
suicidality, provided in consort with treatments for mental disorders and SUDs,
are showing promise. Sample topics include:
o Improved measures of suicidality are needed to gauge the effectiveness of
current treatments for mental disorders, AUDs and SUDs, and treatments under
development for reducing suicidality, both in regard to immediate and long-term
outcomes. Measures with cross-cultural acceptability and appropriateness are a
priority.
o Efforts to identify factors influencing clinical efficacy of medications
using human laboratory behavioral pharmacology paradigms are needed. Prior to
beginning phase 2 clinical trials, potential medications can be screened in the
laboratory to determine the following: 1) the medication's impact to reduce
craving and/or to diminish the negative symptoms of alcoholism; 2) likelihood
of adverse events and/or suicide ideation, especially in the presence of SSRIs
and alcohol; 3) pharmacokinetics for medication combinations; and 4) optimal
dosing regimens. Studies are sought which develop and expand use of these
human laboratory paradigms.
o Studies to identify possible interactions of medications to treat suicidality
among AUD and mental illness as well as interactions with alcohol are needed to
determine what is safe, effective treatment. Pharmacokinetic studies might also
be appropriate.
o Trials to test the efficacy of innovative treatments for persons at high risk
for suicidal behavior, in combination with established treatments for persons
with mental disorders, SUDS and AUDs with high suicidality risk are needed.
Determining whether treatment for SUDs and AUDs, such as psychosocial and
behavioral treatments (e.g., "12 step" programs), reduces suicide risk, remains
to be explored.
o Efforts to evaluate the efficacy of established and novel pharmacological
agents for AUD and SUD patients with comorbid psychiatric disorders are needed.
Appropriate combination and sequencing of pharmacological, behavioral and
psychosocial therapies need to be explored for patients suffering from
suicidality and two or more concurrent disorders.
o Innovative trials of suicide prevention and suicide related conditions (e.g.,
SUD and AUD) as part of multi-faceted service delivery approaches, such as
short-term hospitalization or intensive day treatment in the public or private
sectors are needed.
o Trials are needed to test the efficacy of treatment approaches among
understudied and/or vulnerable groups that experience suicidality, who have
special needs or complex symptomatology or circumstances. These include
pregnant and postpartum women; ethnic minorities and immigrant groups; rural
populations; incarcerated youth; older adults with physical illness; and persons
with multiple comorbid disorders (e.g., PTSD, AUD, SUD, depression).
o Identifying the mechanisms of action of effective interventions for persons
with suicidality and associated disorders (mental illness, AUDs, SUDs) in order
to facilitate the eventual dissemination of evidence-based interventions are
needed.
o Further development of techniques for the engagement, retention, and
adherence of comorbid patients in treatment (e.g., motivational interviewing,
contingency management) as they may need to be adapted to address specific
patterns of comorbidity and suicidality.
c. Multi-level Prevention Approaches
The IOM report, Reducing Suicide, highlighted the particular challenges in
assessing population-based prevention approaches due to the relatively low base
rate of suicide deaths, and the limited prevalence data on suicide attempts and
ideations. However, it also highlighted the opportunities to examine whether
the substantial number of preventive interventions that have proved successful
in reducing early substance use, drinking and driving, binge drinking, and
aggression, also reduce suicidality. These intervention approaches are
developmentally specific and wide-ranging; involving parents, extended families,
health professionals, schools, worksites and employee assistance programs, and
community agencies and task forces. Including suicidality outcomes in these
preventive intervention investments would be an efficient means of testing the
potential power of these approaches in reducing suicide risk. Similarly,
suicidality prevention and treatment interventions for youth may also confer
some protection from involvement with alcohol and other substances. Other
preventive intervention opportunities include:
o Assessing the efficiency of prevention of early comorbid patterns; For
example, does prevention of anxiety reduce the risk for depression and substance
use, as well as suicidality?
o Community-level and policy interventions, such as those to reduce underage
drinking, alcohol-related community problems and other unwanted behaviors, can
be evaluated for their potential effects on suicidality. Examples include
evaluations of efforts to reduce commercial availability of alcohol to youth
under age 21, increased enforcement of driving under the influence (DUI) laws,
changes in laws and enforcement regarding antisocial behavior, and public
education efforts to improve health and safety.
o Some policy changes may occur that are not necessarily instituted for the
purpose of reducing population risk, but may have unanticipated effects
relevant to suicide. These policies may provide opportunities to conduct
"natural experiment" studies. Such research may involve prospective
longitudinal studies of intervention and control sites, comparisons across
communities, or use of archival data.
o Where risk of suicide is excessively high in particular communities (e.g.,
some American Indian tribes), it may be appropriate to approach the problem
simultaneously at universal, selective, and indicated levels. Interventions
could be adapted to subpopulations within the community according to their
relative risk and the intensity of their interactions with vulnerable
individuals (e.g., such an approach is being used to address the problem of
Fetal Alcohol Syndrome [FAS] among American Indian tribes).
o School-based suicide preventive interventions have included awareness
training, screening, skills-building, and social support-building for students,
and gatekeeper and post-intervention training for school staff, but few have
been well specified or evaluated for efficacy or safety. Although a number of
popular programs are assumed to be useful, the costs and benefits of such
existing programs need more systematic evaluations. Refinement of existing
programs, as well as tests of new theory-driven interventions, are also needed.
o Prevention approaches that carefully consider cultural expectations and
assumptions about suicidality when addressing both known higher risk (gay,
lesbian, transgendered and bisexually active youth) and lower risk youth
(African Americans) are needed to better match the needs of certain subgroups
of youth, as well as avoid untoward intervention effects.
d. Services Research
Due to the lack of empirically-based assessment and treatment approaches to
reducing suicidality, there are few practice guidelines to implement in order
to improve the quality of care provided in emergency, specialty, or primary care
sectors. Alternatively, there may be helpful practice policies that are not
adequately implemented, while other policies may unintentionally limit efforts
to provide better care. Topics include:
o Tests of emergency care approaches to adequately assess, treat, and
facilitate follow-up care of suicide attempters are needed.
o Research within settings where high-risk populations can be found are also a
priority, such as juvenile detention, unemployment offices, farm credit offices,
home health care, and youth and women's shelters. Investigators are encouraged
to identify emotional states or conditions most associated with suicidality,
including loss of self-worth, perceived loss of desired level of functioning,
hopelessness, and depression. Investigators are encouraged to draw from the
behavioral science literatures on identity, self-esteem, culture, and emotion
dysregulation.
o Research is needed to improve the quality of: suicidality assessment,
referral, treatment and management, and consequent system changes for specific
settings that reach large segments of the population, such as schools, primary
care, the criminal justice system, and the workplace.
o Information on the effectiveness of screening for suicidality in primary care
in reducing suicide risk, and information on the possible costs of such efforts,
or unintended harms, is needed.
o Because few males access traditional sites of care prior to suicide death,
tests of acceptable outreach and referral practices through non-health care
settings (e.g., unemployment offices, workplace, DWI court, agricultural loan
offices) are needed.
o Many states have initiated their own suicide prevention plans, most of which
involve multiple sectors (education, mental health, law enforcement). There is
a critical need to develop evaluation strategies to assess the safety and
effectiveness of these efforts, in collaboration with suicide prevention and
SUD, AUD and mental illness services advocates, and state officials.
e. Contagion, Media Campaigns, and Health Education
Public health approaches have used mass-media campaigns to varying success to
reduce smoking, alcohol and other substance use, but few evaluation efforts have
been implemented to test campaigns to reduce suicide. Evidence of suicide
contagion from media coverage of youth suicide deaths has been one reason for
concern in mounting broad campaigns. If the National Strategy for Suicide
Prevention is to be adequately implemented, safe approaches to building
awareness in the public about suicide and its risk factors must be developed.
o Further research on methods of disseminating information and messages related
to suicidality (e.g., stories about celebrity decedents; descriptions of types
of suicide methods; descriptions of mental illness, AUD/SUD as risk factors) for
various subgroups (youth at risk; parents of youth not at risk; adult men;
alcohol abusers) is needed, specifically to understand the risks of untoward
effects (e.g., possible suicide contagion). Research by multi-disciplinary
groups (social psychology, marketing, health education) is considered essential.
(See addendum to related PA-02-131, "Dissemination and Implementation Research
in Mental Health,"
http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-009.html)
o Due to the "triple stigma" around suicidality, mental illness, and AUDs and
SUDs, safe and innovative education and referral efforts are needed to reach
persons least likely to seek help (e.g., white males; traditionally underserved
populations skeptical about mental health or SUD treatment). In addition,
research on the effectiveness of alternative methods of education and referral
efforts, such as faith-based or other community organizations, is needed.
o Research on the inclusion of information on suicidality within ongoing
dissemination efforts for related mental illnesses (e.g., depression, bipolar
illness) or harm reduction campaigns for AUDs and SUDs by industry, nonprofit,
and federal efforts, is encouraged.
f. Ethical and Safety Issues
o The study of the competency of individuals at high risk for suicidal behavior
to participate in research is needed. Various approaches to addressing
questionable competency (e.g., advance directives) need to be evaluated.
o Potentially unique issues to suicide research, such as whether repeated
assessment of suicidality increases risk, needs to be determined for various
subgroups (e.g., youth) and contexts (schools, primary care) for screening and
intervention research.
o Development and evaluation of risk management strategies that could be
incorporated into intervention trials in order to optimize the inclusion of
persons at high risk for suicidality is needed.
o Innovative research on the ethics and safety of mass-media public service
campaigns, specifically around determining, and minimizing unintended negative
consequences of these campaigns, is encouraged.
Other institutes and agencies with relevant resources and related interests:
The Substance Abuse and Mental Health Services Administration (SAMHSA) Office of
Applied Studies supports surveys assessing prevalence of suicidality and related
risk factors (see http://www.drugabusestatistics.samhsa.gov/).
SAMHSA's Center for Mental Health Services supports the National Suicide
Prevention Resource Center (see: http://www.sprc.org),
the National Suicide Strategy Indicators project (see http://www.nsspi.org)
as well as demonstration programs in the prevention and treatment of mental and
substance abuse disorders, including suicide prevention. Demonstration funding
opportunities can be found at http://www.samhsa.gov/.
The Centers for Disease Control and Prevention's (CDC) National Center for
Injury Prevention and Control (NCIPC), focuses on addressing the need for
effective, population-based prevention and intervention strategies regarding
self-directed violence. NCIPC's activities fall into four categories:
disseminating information about suicidal behavior and its prevention and
supporting the implementation of proven programs and policies; applying
scientific methods to evaluate the effectiveness of intervention and prevention
programs; enhancing the knowledge base about risk and protective factors and
the consequences of suicidal behavior; and continuing to improve methods for
data collection in order to describe and track suicidal behaviors. The NCIPC
internet site is http://www.cdc.gov/injury.
The Indian Health Service (IHS) supports suicide prevention activities through
consultation and technical assistance to tribes through 12 Area Offices.
Additionally, IHS operates nine regional alcohol and substance abuse treatment
centers for youth 12-18 years of age (see http://www.ihs.gov). Reports
on the prevalence of various markers of Indian health by region, including
suicide mortality, are available at
http://www.ihs.gov/publicinfo/publications/index.asp.
Health Resources and Services Administration supports suicide prevention
activities through the Bureau of Primary Health Care, the HIV AIDS Bureau,
Maternal and Child Health Bureau (MCHB), and Office of Rural Health Policy
(see http://www.hrsa.gov). The MCHB provided
funding for the Children's Safety Network that has developed youth suicide
prevention activity inventories across various states (see
http://www.childrenssafetynetwork.org/links/youthsp.asp)
MECHANISMS OF SUPPORT
This PA will use the NIH research project grant (R01), small grant (R03), and
exploratory/developmental grant (R21, R34) award mechanisms. As an applicant,
you will be solely responsible for planning, directing, and executing the
proposed project. Ancillary studies to clinical trials (e.g., see
http://grants.nih.gov/grants/guide/pa-files/PAR-00-095.html)
and/or competing supplements to existing descriptive studies of risk and
protective factors related to suicidality, can also be used.
The Small Grant (R03) provides 2 years of funding with a maximum of $50,000
direct costs for each year. Instructions for the R03 application can be found
at (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html).
The Exploratory/Developmental Grant (R21) provides 2 years of funding with a
maximum of $275,000 direct costs over the entire budget period; with no 1 year
exceeding $200,000. Instructions for the R21 application may be found at:
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.
The R34 mechanism provides up to $450,000 direct costs for 3 years with no one
year exceeding $225,000 for research on 1) the development and/or pilot testing
of new or adapted interventions, 2) pilot testing interventions with
demonstrated efficacy in broader scale effectiveness trials, or 3) innovative
services research directions that require preliminary testing or development.
Instructions for R34 applications can be found at
(http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html).
This PA uses just-in-time concepts. It also uses the modular budgeting format.
(see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out
the proposed research is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two areas:
scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Jane L. Pearson, Ph.D.
Chair, Suicide Research Consortium
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD 20892-9635
Telephone: (301) 443-3598
FAX: (301) 594-6784
Email: jp36u@nih.gov
Lynda Erinoff, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5153, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 402-1972
FAX: (301) 480-2543
Email: le30q@nih.gov
Charlene E. LeFauve, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505, MSC 7003
Bethesda, MD 20892-7003
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-9401
FAX: (301) 443-8774
Email: clefauve@NIAAA.nih.gov
Ann O'Mara, Ph.D., M.P.H., RN
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room 2011, MSC 7340
Bethesda, MD 20892-7340
Telephone: (301) 496-8541
FAX: (301) 496-8667
Email: omaraa@mail.nih.gov
Sidney M. Stahl, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Room 533, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
FAX: (301) 402-0051
Email: Sidney_Stahl@nih.gov
o Direct your questions about financial or grants management matters to:
Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: jk173r@nih.gov
Catherine Mills
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: cm108w@nih.gov
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 MSC 7003
Bethesda, MD 20892-7003
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2434
Email: jsimons@niaaa.nih.gov
Jane Paull
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892
Telephone: (301) 496-2184
Email: Jp97x@nih.gov
Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: whippl@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which are
available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
format. The modular grant format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes
step-by-step guidance for preparing modular grants. Additional information on
modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application
for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member and
IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised version
of these grant application types. Additional information on this policy is
available in the NIH Guide for Grants and Contracts, October 19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the checklist, and five signed photocopies in one package
to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.
The CSR will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept any
application that is essentially the same as one already reviewed. This does
not preclude the submission of a substantial revision of an application already
reviewed, but such application must include an Introduction addressing the
previous critique.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8
weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of established
PHS referral guidelines. An appropriate scientific review group convened in
accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council
or board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to discuss the following aspects of
your application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria in
assigning your application's overall score, weighting them as appropriate for
each application. Your application does not need to be strong in all categories
to be judged likely to have major scientific impact and thus deserve a high
priority score. For example, you may propose to carry out important work that
by its nature is not innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims of
your application are achieved, how do they advance scientific knowledge? What
will be the effect of these studies on the concepts or methods that drive this
field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does your project challenge existing
paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. (See criteria included in the section
on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans
to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. (See Inclusion Criteria in the sections on Federal
Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS 398
research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds with
all other recommended applications. The following will be considered in making
funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for assessment
of patient eligibility and status, rigorous data management, quality assurance,
and auditing procedures. In addition, it is NIH policy that all clinical trials
require data and safety monitoring, with the method and degree of monitoring
being commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Investigators are also referred to
http://www.nimh.nih.gov/research/highrisksuicide.cfm for safety
and ethical issues specific to suicidality research.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on
October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects.
You will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide, in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s)to be used in the proposed research. Applications that do
not provide this information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to provide
public access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore, we
caution reviewers that their anonymity may be compromised when they directly
access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting priority areas. This PA is related to
one or more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under the authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.